GB/T 1685-1982
Replaced
GB/T 45481-2025
Active
National standards
GB/T 45481-2025 Silicone rubber compounds—Application for medical catheters
GB/T 45481-2025 Silicone rubber compounds—Application for medical catheters
Price:
$ 33.00
Basic Information
Standard Code:
GB/T 45481-2025
Standard Type:
National standards
Standard Status:
Active
is_force_gb:
no
CCS Name:
Synthetic rubber
ICS Name:
Rubber
Publish Date:
2025-03-28
Implement Date:
2025-10-01
Pages:
12 pages
Scope
This document specifies the naming, technical requirements, inspection rules, and marking, packaging, transportation, and storage of silicone rubber compounds for medical catheters, and describes the corresponding test methods.
This document is applicable to the preparation of silicone rubber compounds for temporary and short-term contact medical catheters (hereinafter referred to as "compounds").
Note: According to the "Classification Rules for Medical Devices", medical catheters are classified as Class II medical devices in this document.
Development Information
Referenced Standards
GB/T 528-1998 Rubber,vulcanized or thermoplastic—Determination of tensile stress-strain properties
GB/T 528-2009 Rubber,vulcanized or thermoplastic—Determination of tensile stress-strain properties
GB/T 529-1999 Rubber,vulcanized or thermoplastic—Determination of tear strength (Trouser,angle and crescent test pieces)
GB/T 529-2008 Rubber,vulcanized or thermoplastic—Determination of tear strength(Trouser,angle and crescent test pieces)
GB/T 531.1-2008 Rubber,vulcanized or thermoplastic—Determination of indentation hardness—Part 1:Duromerer method(Shore hardness)
GB/T 16886.1-2001 Biological evaluation of medical devices—Part 1:Evaluation and testing
GB/T 16886.1-2011 Biological evaluation of medical devices—Part 1:Evaluation and testing within a risk management process
GB/T 16886.1-2022 Biological evaluation of medical devices—Part 1:Evaluation and testing within a risk management process
GB/T 16886.5-2003 Biological evaluation of medical devices—Part 5:Test for in vitro cytotoxicity
GB/T 16886.5-2017 Biological evaluation of medical devices—Part 5:Tests for in vitro cytotoxicity
GB/T 16886.6-1997 Biological evaluation of medical devices—Part 6:Tests for local effects after implantation
GB/T 16886.6-2015 Biological evaluation of medical devices—Part 6:Tests for local effects after implantation
GB/T 16886.6-2022 Biological evaluation of medical devices—Part 6:Tests for local effects after implantation
GB/T 16886.10-2000 Biological evaluation of medical devices—Part 10:Tests for irritation and sensitization
GB/T 16886.10-2005 Biological evaluation of medical devices—Part 10:Tests for irritation and delayed-type hypersensitivity
GB/T 16886.10-2017 Biological evaluation of medical devices—Part 10:Tests for irritation and skin sensitization
GB/T 16886.10-2024 Biological evaluation of medical devices—Part 10:Tests for skin sensitization
GB/T 16886.11-1997 Biological evaluation of medical devices—Part 11:Tests for systemic toxicity
GB/T 16886.11-2011 Biological evaluation of medical devices—Part 11:Tests for systemic toxicity
GB/T 16886.11-2021 Biological evaluation of medical devices—Part 11:Tests for systemic toxicity
GB/T 28112-2011 Determination of residual dimethylcyclosiloxane volatiles in silicone rubber
GB/T 32365-2015 Silicone rubber compound—Classification and system nomenclature
Related Standards
GB/T 3515-1983
Replaced
GB/T 3515-1983 Rubber, vulcanized—determination of carbon black content—pyrolytic method
GB/T 4497-1984
Replaced
GB/T 4497-1984 Vulcanized rubber—Determination of total sulphur content—Oxygen combustion flask method
GB/T 6030-1985
Replaced
GB/T 6030-1985 Vulcanized rubber—Determination of carbon black dispersion—Micrographic method
GB 5577-1985
Replaced
GB 5577-1985 Codification of types for synthetic rubbers
GB/T 1688-1986
Replaced